AccessGUDID - DEVICE: Encore (10818634020960)

GUDID

Device Identifier (DI) Information

Brand Name: Encore
Version or Model: 71-2018480
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71-2018480
Company Name: Bosma Enterprises

Primary DI Number: 10818634020960
Issuing Agency: GS1
Commercial Distribution End Date: March 19, 2024
Device Count: 50
Labeler D-U-N-S® Number*: 878070325 *Terms of Use

Device Description: Encore Latex Underglove Surgical 8.0 - 50 Pair/Box

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47178	Hevea-latex surgical glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture, and ozone.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8.0

Device Record Status

Public Device Record Key: d0f56fc1-204b-4111-b121-91d6625c89ce
Public Version Date: March 20, 2024
Public Version Number: 2
DI Record Publish Date: July 01, 2021